3-Day MDSAP & ISO 13485 – $1895

MDSAP & ISO 13485 Course

We teach you how to use auditing to improve your organization

Days: 3 • CTUs: 3.6

Monday-Thursday 7:30 am – 5:30 pm

Days: 3 • CEU Hrs: 2.4

Audience: Beginner to Advanced

Overview:

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO 13485 standard and MDSAP requirements to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting. This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing and apply MDSAP and ISO 13485 requirements. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Prerequisites

There are no required prerequisites, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful. All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.